Laryngo-Tracheal Tissue-Engineered Clinical Transplantation

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The dates of the recruitment period are from June 2012 to January 2014. The recruitment process have been done in medical clinic: Krasnodar Regional Hospital #1.

Pre-assignment Details

Arm/Group Title

Stem-cell Seeded Bioartificial Trachea

Arm/Group Description

Stem-cell seeded bioartificial trac...

Arm/Group Description

Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ

Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ

Safety of the tissue engineered trachea measured by occurrence of adve...

Description

Safety of the tissue engineered trachea measured by occurrence of adverse events throughout 12 months post operative follow up

Time Frame

12 months post operative follow up

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Stem-cell Seeded Bioartificial Trachea

Arm/Group Description:

Stem-cell seeded bioartificial trac...

Arm/Group Description:

Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ

Overall Number of Participants Analyzed

6

Measure Type: Number

Unit of Measure: participants

0

2.Primary Outcome

Title

Number of Mononuclear Cells (MNCs) Per ml

Description

MNCs were isolated from bone marrow fom each patient, and were counted...

Description

MNCs were isolated from bone marrow fom each patient, and were counted by flow cytometry method. MNC were used for seeding on scaffold.

Time Frame

1 time before seeding on scaffold

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Stem-cell Seeded Bioartificial Trachea

Arm/Group Description:

Stem-cell seeded bioartificial trac...

Arm/Group Description:

Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ

Overall Number of Participants Analyzed

6

Mean (Standard Error)

Unit of Measure: MNCs per ml

2773000
(353579)

3.Secondary Outcome

Title

Number of Survival Patients

Description

To evaluate the survival of patient after transplantation of stem-cell...

Description

To evaluate the survival of patient after transplantation of stem-cell seeded bioartificial trachea during 12 months post operative follow up.

Time Frame

12 months post operative follow up

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

[Not Specified]

Arm/Group Title

Stem-cell Seeded Bioartificial Trachea

Arm/Group Description:

Stem-cell seeded bioartificial trac...

Arm/Group Description:

Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ

Overall Number of Participants Analyzed

6

Measure Type: Number

Unit of Measure: participants

6

4.Secondary Outcome

Title

Number of Disease Free Survival Patients

Description

The disease free survival of patient were evaluated after transplantat...

Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ

Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ

All-Cause Mortality

Stem-cell Seeded Bioartificial Trachea

Affected / at Risk (%)

Total

--/--

Serious Adverse Events Serious Adverse Events

Stem-cell Seeded Bioartificial Trachea

Affected / at Risk (%)

# Events

Total

3/6 (50.00%)

Respiratory, thoracic and mediastinal disorders

Granulation and Fistula † [1]

3/6 (50.00%)

3

†

Indicates events were collected by systematic assessment

[1]

Granulation or fistula resulted in 2 patient into re-transplantation, in 1 patient in explantation and tracheostoma

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events